All patients undergoing general surgical and/or orthopedic indicator operations
that are reported to Prezies-network.

- Exclusion criteria

- Inability to complete 30 days follow-up;
- < 18 years of age;
- Evidence of infection at or adjacent to the operative site;
- History of allergy for chlorhexidine, alcohol or idiophors.

- mec approval received

no

- multicenter trial

yes

- randomised

yes

- masking/blinding

Single

- control

Active

- group

Crossover

- Type

2 or more arms, randomized

- Studytype

observational

- planned startdate

1-jul-2013

- planned closingdate

1-aug-2015

- Target number of participants

4000

- Interventions

Participating hospitals are randomly assigned to either chlorhexidine-alcohol (0.5% chlorhexidine in alcohol 70%) or iodine-alcohol (1% iodine in alcohol 70%)
for preoperative skin antisepsis for a time period of three months. After the first
period of three months, centers will switch to using the other agent for preoperative
antisepsis. Centers will switch each 3 months for 3 times and will actively be contacted
two weeks before a switch will take place.
Patients will undergo routine surgical care and after care. The surgical site will be
assessed regularly during hospitalization, on discharge, at the time of follow-up
evaluation, and whenever SSI occurs.

- Primary outcome

Primary endpoint is the occurrence of SSI within 30 days following surgery or within one year following orthopaedic procedures.

Surgical-site infection data will be recorded postoperatively and sent to the PREZIES network. The rate of surgical-site infection will be evaluated 30 days after patient accrual has stopped. Furthermore, all cases with implants will be evaluated for surgical-site infections one year from the end of the study.

Rationale: Surgical-site infection (SSI) increases morbidity, mortality, length of hospital
stay and costs. Optimization of preoperative skin antisepsis may decrease
postoperative infections. In the Netherlands, chlorhexidine-alcohol and iodine-alcohol
based skin antiseptics are currently used at random in general surgery mostly
depending on local or personal preferences.
Objective: To investigate whether either chlorhexidine-alcohol or iodine-alcohol based
skin antiseptics is more protective against surgical site infections.
Study design: A prospective pragmatic cluster randomised cross-over trial
Study population: Patients > 18 years of age undergoing general-surgical and/or
orthopaedic indicator operations.
Intervention (if applicable): Participating hospitals are randomly assigned to an
alternating schedule of either chlorhexidine-alcohol (A) or iodine-alcohol (B) for
preoperative skin antisepsis for a time period of three months. After each period of
three months for a total study period of one year, hospitals will cross over, resulting in
intervention schedules of either ABAB or BABA.
Main study parameters/endpoints: Primary endpoint: Wound infection within 30 days
after surgery, or 1 year after surgery with a non-humane implant.
Secondary endpoints: (1) Type of wound infection, (2) Opened wounds (3) microbiologic
causes of infection, (4) adverse events
Nature and extent of the burden and risks associated with participation, benefit
and group relatedness: Preoperative evaluation will include a routine medical history,
taking psychical examination, and hematologic and blood chemical laboratory tests.
According to the hospitals assigned cluster, the participant will be subject to painting of
the skin with either chlorhexidine-alcohol or iodine-alcohol immediately prior to surgery.
Both investigational products have been used for decades for surgical site antisepsis
and are considered safe. Minimal side effects have been reported. Participants will
undergo routine surgical care and after care. The surgical site will be assessed during
hospitalization, on discharge, at the time of follow-up evaluation, and whenever SSI
occurs. If SSI is suspected or diagnosed, clinically relevant microbiologic samples will
SKINFECT Trial, version 2.1 24-10-2012
3
be cultured. At 30 days follow-up (or 1 year follow up in case of surgery with non-human
implants), SSI data, collected by PREZIES network, will be analysed.